Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202210850139462 Date of Approval: 17/10/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Modified Rescue High Frequency Oscillatory Ventilation Protocol Improves Outcome in Pediatric Patients with Severe Acute:Respiratory Distress Syndrome: A randomized control trial
Official scientific title Modified Rescue High Frequency Oscillatory Ventilation Protocol Improves Outcome in Pediatric Patients with Severe Acute Respiratory Distress Syndrome
Brief summary describing the background and objectives of the trial High frequency oscillatory ventilation (HFOV) is used mainly as a rescue mode in pediatric acute respiratory distress syndrome (PARDS). Although it may improve oxygenation, its overall benefit is still controversial. We aimed to compare a modified protocol of rescue introduction of HFOV and early weaning to conventional mechanical ventilation (CMV) with CMV in PARDS.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 22/10/2022
Actual trial start date
Anticipated date of last follow up 27/04/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group HFOV group include 30 patients with PARDS who were on HFOV and weaned early to CMV. till patients improve we will put patients with RDS on HFOV till improvement and we will record duration of MV, the length of PICU and hospital stay, oxygenation indices, and mortality. 30
Control Group CMV group included 30 patients with PARDS who will be on CMV Till the patients improve we will put patients with RDS on CMV till improvement and we will record duration of MV, the length of PICU and hospital stay, oxygenation indices, and mortality. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
small children weighing less than 30 kg with severe RDS children weighing more than 30 Kg (maximum weight allowed for the Fabian HFO ventilator), children with pulmonary edema of cardiac origin or as a result of volume overload, or cardiac patients having congenital heart disease, cardiomyopathy, myocarditis, or after cardiac surgery. Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 1 Month(s) 11 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/09/2022 local ethical committee of faculty of medicine of tanta uinversity
Ethics Committee Address
Street address City Postal code Country
Elgeish street Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome duration of MV until discharge from PICU, 30 days, or death
Secondary Outcome length of PICU and hospital stay, oxygenation indices, and mortality until discharge from PICU, 30 days, or death
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital Elgeish street Tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Doaa El Amrousy Motasem street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine of tanta university Elgeish street Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Harakan elmotasem street tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Harakan ahmed.harakan@med.tanta.edu.eg +201013185508 Elmotasem street
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of pediatrics
Role Name Email Phone Street address
Scientific Enquiries Doaa El Amrousy doaamoha@yahoo.com +201289022229 Elmotasem street
City Postal code Country Position/Affiliation
Tanta Egypt Profressor of pediatrics
Role Name Email Phone Street address
Public Enquiries Mohamed Hamza mohamedkashlan@yahoo.com +201020220271 elrakhaa street
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of pediatrics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes summary results will be shared in a word document format. Statistical Analysis Plan,Study Protocol within 12 months of the end of the study controlled access after approval of the authors
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information